Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk
- Determine whether the genomic profiles of breast epithelial cells of high-breast
cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition,
express a signature indicative of high-risk.
- Determine whether women identified to express a "high-breast cancer-risk" signature
will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which
should have induced breast differentiation and genomic changes that would serve as
biomarkers indicative of decreased breast cancer risk.
OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three
times weekly. Treatment continues weekly for 90 days in the absence of unacceptable
Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and
day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67
immunohistochemical staining for cell proliferation, cDNA microarray for gene expression,
and serum studies for hormone levels and biomarker determinations.
After completion of study treatment, patients are followed for 24 weeks.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Measurement of gene expression in breast epithelial cells obtained for asymptomatic high breast cancer risk nulliparous premenopausal women at baseline, after treatment with r-hCG at 90 days, and at 270 days from baseline
90 days and 270 days from baseline
Jose Russo, MD, FCAP
Fox Chase Cancer Center
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|